As the Chief Information Security Officer (CISO) at Centra Technology AB, I am responsible for defining, promoting, and overseeing an Information Security Management System (ISMS) compliant with the ISO 27001:2022 standards family and privacy regulations. I collaborate with key stakeholders to assess and mitigate risks for the fast-growing Centra e-commerce platform. We actively build and support a security and quality culture in the rapidly growing scale-up offering the fashion brand commerce platform.

I led the regulatory consulting group at Star. Our team goal was to help companies define, implement, and certify various management systems in the organizations, including:1. Quality Management System - ISO 134852. Risk Management System - ISO 149713. Information Security Management System - ISO 270014. Software Development Life Cycle Management SystemWe also helped companies to define and implement Management Systems compliant with regulations such as: 1. Medical Device Regulation (MDR)2. 21 CFR 8203. In Vitro Diagnostic Regulation (IVDR)4. General Data Protection Regulation (GDPR)5. Health Insurance Portability and Accountability Act (HIPAA)As a regulatory consulting group, we were in charge of defining and certifying management systems and placing medical device-type products on the market.

I worked as a Product Manager of ins2outs services. ins2outs is a management system that helps organizations meet regulatory requirements. As a product manager, I was responsible for coordinating product value proposition, supporting the design and development team as a Product Owner, and coordinating service provision activities of the Amazon Web Services deployed service. I also supported sales and marketing activities and product rollouts for new and existing clients.

As an Information Security Officer, I was responsible for defining and maintaining the Information Security Management System (ISMS) compliant with ISO 27001 for large and small IT organizations. My responsibilities covered supervision of the system, educating employees, and monitoring and resolving security weaknesses and incidents. I worked closely with research and development teams and operations teams, managing digital products provided to global customers on AWS cloud solutions. I was also responsible for updating and extending the ISMS to the new revision of ISO27001:2022. My duties also covered compliance with privacy regulations like the General Data Protection Regulation (GDPR), which focused on technical and organizational measures applied to assure data privacy.

I worked as a consultant on an In Vitro Diagnostics medical device Phivea®, from gMendel for the EU/Danish market. The IVD MD was a Software-as-a-Medical-Device (SaMD) solution that used Artificial Intelligence/Machine Learning for the screening of rare genetic disorders based on the DNA sequencing process. I was consulting and supporting the product life cycle (PLC) and product documentation management activities. My duties covered the co-creation of an intended purpose, regulatory strategy, product requirements, product management plan, verification and validation strategy, performance evaluation plan, post-market surveillance, technical documentation, and finally, an IFU. In addition to placing the IVD MD on the market, the Product Manager assigned by the client was trained on the relevant processes and, as a result, took over the full scope of product management activities.The product was a highly innovative solution and was placed on the market in a mere nine months from the start.

I worked as a Project Manager of a software development team, that developed an MVP version of Phivea® from gMendel - an in vitro diagnostic (IVD) medical device (MD). The software was developed accordingly to the IEC 62304 standard and “B” software safety classification/moderate level of concern. The IVD MD was a Software-as-a-Medical-Device (SaMD) solution that used Artificial Intelligence/Machine Learning for the screening of rear genetic disorders based on the DNA sequencing process.The Software Development Life Cycle (SDLC) team consisted of two Developers, one Solution Architect, a Business Analyst, a DevOps, and a Quality Assurance Engineer. On the technical aspect, the project used Artificial Intelligence, Machine Learning, Java, docker, and fastq technologies. As a result of the project, both the engineering solution as well as full documentation required by IEC62304 and IEC82304 standards were delivered. The release version passed all specified test cases during the verification and validation phases. The first release of the software was delivered in mere 7 months after the project kick-off.

ins2outs is an Organization Management System that helps companies to meet regulatory requirements. I manage ins2outs as a Product Manager. With respect to outbound activities, I take part in product strategy definition and update, market research, and collecting and processing customer and user feedback. I am engaged in the preparation and updating of ins2outs Business Model Canvas and Value Proposition Design. Based on market analysis, together with the Top Management team, we define the pricing strategy for this product. I take part in marketing events and the preparation of marketing and supporting materials. As far as inbound activities are concerned, I work closely with the SDLC team responsible for the development of ins2outs new product versions. I deliver and explain product roadmaps, participate in software development events, and finally approve new releases/rollouts on production environments. I am also part of the Service Delivery team responsible for all levels of product support activities.

As a CEO, I managed an IT solution provider from Wrocław, Poland. I was responsible for strategy and operations planning and execution. As the company holds both ISO13485 (Quality Management System) and ISO27001 (Information Security Management System) certifications, I was in the top management group responsible for planning and running the integrated management system. Along with our COO, I was responsible for global business development activities related to IT services. That included defining sales and marketing strategy, executing quarterly plans, and bidding negotiations and contract closure activities. I was also responsible for customer relationship management with current and past clients. In conjunction with the rest of the Top Management, I prepared the budget and controlled its execution. With the Human Resources Manager, we supervised recruitment, building awareness, and developing competencies in the organization. Finally, being part of the whole Pro4People team, I cultivated the company culture focused on building IT products that are safe, secure by design, easy to use, and offer real benefits for end-users.

I have worked as a regulatory consultant helping both Pro4People and other companies to define and certify their management systems. I specialize in the following standards/regulations:• ISO13485 – Medical Device – Quality Management System (QMS)• ISO14971 – Medical Devices – Application of Risk Management to Medical Devices• IEC62304 – Health Software – Software Life Cycle Processes (SDLC)• ISO27001 – Information Technology – Information Security Management System (ISMS)• General Data Protection Regulation• 21 CFR 820As a certified ISO27001, ISO13485 auditor and software engineer, I defined and documented the complete know-how sets, enabling any organization to promptly start to define its management system for standards such as ISO13485, ISO14971, IEC62304, ISO27001. I have coordinated or taken part in multiple QMS or ISMS certification projects for both Pro4People as well as ins2outs client organizations. I managed such projects for a wide range of organizations, but always in the domain of medical devices, health software, IT, and cloud-related products. Just to mention my biggest achievements: convincing R&D teams to follow IEC62304 😊 along the medical device product life cycle, defining and certifying ISO13485 compliant QMS (in five months), and doing the same with multiple ISMS systems.

I worked in the position of a software development project manager on various projects at Pro4People. Two I would like to mention here were IoT systems for predictive maintenance and Software as a Medical Device solution for skin cancer diagnosis with an AI component. In both of these projects, I was responsible for SDLC project management following the Agile/Maturity Pro4People approach. I was responsible for turning product owner delivered product roadmaps into Sprints and delivery of releases on specified dates. I was managing fully-staffed software development teams with such roles as Business Analyst, UI/UX Designer, Architect, TechLead, Developers, Quality Assurance and DevOps engineers. The biggest project team I have managed consisted of 22 engineers working in two independent subteams following the Agile/Maturity methodology. I am an experienced project manager with several years of training and over 10 years of experience in managing software projects.

For two years I was leading a project aiming at ISO 13485 Quality Management System definition and certification at S3 Group organization – an international IT solutions provider. The goal of the project was to define and restructure the company's already existing Quality Management System (QMS) so that it could be compliant and certified with ISO 13485 standard. The QMS had to cover other standards and regulations, such as IEC 62304, ISO 14971, and FDA 21 CFR 820. As a project manager of this organizational change, I coordinated teams geographically distributed between Wroclaw and Dublin. I was acting as a liaison between top management and engineering teams and over 50 stakeholders. I had to use all my expertise as a software developer and an R&D team manager to tailor the system to the specific needs of the IT organization. Such a change can never happen alone so in this project I worked closely with other R&D and PIO project team members and with direct support from the General Manager of the Wrocław R&D office. I was reporting directly to the company’s Top Management and PIO Manager. Together, we were able to define the Quality Management System, execute a major change in the organization, and prove the organization’s maturity with an independent certification audit with BSI. This enabled the company to further develop its IT Services in the pharma market.

I was responsible for greenfield investment and building an R&D department of an established German organization providing alignment and condition monitoring services for the industry. I took part in building the R&D team, recruitment, project portfolio coordination, and organization systems definition. I was reporting to the General Manager of the Polish subsidiary and to R&D Manager from Munich. The biggest challenge was to build a strong company culture and integrate a new R&D organization with the rest of the global organization. That was achieved by focusing on the high quality of delivered products from the very beginning, organizing employee exchange programs, and providing services in non-competitive areas. Technologically, we were delivering embedded software developed mainly in C++ for industrial devices. We developed products for domains such as shaft alignment, steam turbine alignment, water turbine alignment, condition monitoring, etc.My biggest achievement: building an R&D organization that has lasted for over 20 years and has been assessed as one of the top R&D locations.

I worked as a C++ developer and project manager for over 8 years on various embedded projects. Together with the project team, we developed products for shaft aligning, steam and water turbine alignment, low-speed turbine rotor balancing, etc. I worked as a C++ embedded developer, with Qt library, and Linux OS as a final execution environment. I was responsible for both front-end implementation as well as business logic. I developed several algorithms especially in the domain of industrial business logic, with a very strong focus on their reliability and high accuracy. I have always concentrated on good software engineering principles, OOP, software engineering, and continuous integration enabling the company to re-use already developed and verified libraries/business logic from one product version to another. Even now, I can see some of the released products, still being used in the field and serving industrial clients 😊. My biggest achievements: • co-developing the first version of the CENTRALIGN product, the most challenging engineering solution for the alignment of bores, bearings, and diaphragms• co-developing the first version of the Shaft Alignment application, the most popular industrial alignment application.

As a Software Developer, took part in the development of a multi-layer client-server HR system. Later on, one of the projects for ZUS ( Social Insurance Company), took part in the design and implementation of external interfaces between ZUS and third-party insurance companies.